Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Status Recruiting

Clinical Trial Summary

Data will be collected with 3 vascular imaging devices (IntraOx Vioptix, Newark, CA; Hyperview, HyperMed Imaging, Memphis, TN; Snapshot NIH, Kent Imaging, Calgary, Alberta, Canada). The wound will be imaged with the 3 devices at index research encounter (this will count as the initial pre-operative imaging if the patient requires surgery), before surgery for interval or additional surgeries, during surgery, and during clinic follow-up (one set of imaging approximately every 3-5 weeks) visits for a maximum follow up time of 12 months or until the wound is documented as healed, whichever occurs first. The investigators will collect data from the medial and lateral angiosomes on the dorsum and plantar aspects of the foot and the anterior and posterior leg. Subject data will be obtained from the patient by oral history and physical exam and the medical records of patients of the investigators: vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement and off-loading. Collection of lab data will be obtained such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care. Imaging with the three devices is research-only and is not standard of care.

Clinical Trial Description

This is a prospective, observational study. All medical and surgical care provided to the patient will be standard of care. Once a patient is identified as having a lower extremity ulceration (includes lower extremity wound of any cause, a surgical incision, a flap or graft) and consent to participation, their lower extremity will be imaged. They will be imaged before, during, and on post-op day 1 if they require surgery and for each surgery related to the ulceration. They will also be imaged once a month in follow up for up to a total of 12 months or healing of the wound, whichever comes first. The 3 instruments do not touch the patient and are being evaluated on their ability to predict wound healing. They are research only and not standard of care, and are not being used to determine care. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04232631
Study type	Observational
Source	University of Texas Southwestern Medical Center
Contact	Debby Noble
Phone	2146488686
Email	Debby.Noble@UTSouthwestern.edu
Status	Recruiting
Phase
Start date	April 28, 2021
Completion date	September 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.